Clinical trial · Interventional
HPV-Based Screen-and-Treat Demonstration Project in Lilongwe
A Novel Cervical Cancer Screen-and-Treat Demonstration Project With HPV Self-testing and Thermocoagulation for Women in Lilongwe Malawi
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to assess completion and performance of the following novel invasive cervical cancer (ICC) screen-and-treat algorithm among 625 HIV-positive women in Lilongwe, Malawi: 1) rapid testing of self-collected vaginal brush for primary high risk (hr)-human papillomavirus (HPV), 2) same-day visual inspection with acetic acid (VIA) for women who are hr-HPV positive, and 3) thermocoagulation for VIA positive/ablation-eligible (by cervical colposcopy) women.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| HIV Infections | — | UNRESOLVED | — |
| HPV Infection | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| VIA and thermocoagulation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- VIA and thermocoagulation
- description
- Participants will undergo same day VIA and thermocoagulation
- interventionNames
- Procedure: VIA and thermocoagulation
Primary outcomes (3)
- measure
- Same-day Visual Inspection With Acetic Acid (VIA) Rate
- timeFrame
- Baseline
- description
- The proportion of women who were HPV-positive and underwent same-day VIA following self-collected vaginal sampling was assessed, including both HIV-positive and HIV-negative participants. As per the study protocol, data were not stratified by HIV status for this outcome due to lack of scientific rationale for a difference in same-day VIA completion by HIV status.
- measure
- Same-day Thermocoagulation Rate Among Women Who Were HPV-positive and Ablation-eligible by Colposcopy Triage
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
- Maximum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: 1. Females ≥ 25 years of age at study entry and ≤ 50 years of age (per current Malawi National Cervical Cancer Control Program guidelines for screening). 2. Ability and willingness of participant to provide written informed consent. Exclusion Criteria: 1. Current or prior history of cervical, vaginal, or vulvar cancer or dysplasia 2. Current symptomatic sexually transmitted infection requiring treatment (women will be allowed to be in the study upon successful treatment) 3. Prior HPV vaccination. 4. Participants with known allergy to acetic acid. 5. Participants with a history of total hysterectomy. 6. Participants who are pregnant or plan on becoming pregnant during the study period. 7. Participants who are less than 12 weeks postpartum. 8. Participants with other illnesses that would limit compliance with study requirements or in the opinion of the investigator or designee, have a problem that would make participation in the study unsafe or complicate interpretation of study findings.
References
Publications (0)
Data not yet available